Glow-in-the-Dark dye could help surgeons find hidden tumors in kids
NCT ID NCT06915727
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a fluorescent dye called pafolacianine (Cytalux) can help surgeons see and remove solid tumors in children and teens during surgery. The dye targets cancer cells and lights up under a special near-infrared camera. Up to 20 participants aged 6 months to 17 years with solid tumors in the neck, chest, abdomen, pelvis, or limbs will receive the dye before surgery. The goal is to see if this technique improves the accuracy of tumor removal compared to standard methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pafolacianine (Cytalux), a fluorescent imaging dye given intravenously
- What this could lead to
- If successful, this could help surgeons more accurately locate and remove all cancerous tissue in children with solid tumors, potentially reducing the need for repeat surgeries.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to all children. The dye's effectiveness and safety in pediatric patients are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willingness of research participant or legal guardian/representative to give written informed consent * Age 6 months to 17 years * Have a diagnosis, or a high clinical suspicion, of a solid tumor in the neck, chest, abdomen, pelvis, or extremities with a plan for surgical resection including embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, germ cell tumors. Children may undergo surgical resection or biopsy of a solid tumor that is suspected to be malignant without a separate preoperative biopsy; therefore, the tumor type may not be definitively known preoperatively Exclusion Criteria: * Previous exposure to Cytalux™ (pafolacianine) injection * Any medical condition that in the judgement of the investigators could potentially jeopardize the safety of the participant * History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Participants with a medical history of 'idiopathic anaphylaxis' will require evaluation * History of allergy to any of the components of Cytalux™ (pafolacianine) injection * Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule * Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug. Investigational trials involving administration of drugs or vaccines which are already Food and Drug Administration (FDA)-approved, such as Children's Oncology Group cooperative trials, are okay * Known sensitivity to fluorescent light * Pregnancy * Unable or unwilling to discontinue folic acid, folate supplements, and multi-vitamins containing folate 48 hours prior to drug administration * Renal failure on dialysis or estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.72m\^2 as measured by the U25 eGFR equation for patients ≥1 year(s) of age. For patients \< 1 year of age, creatinine \> 2x the upper limit of normal will serve as an exclusion criteria. Creatinine will be measured by enzymatic assay with calibration traceable to the international standard reference materials and minimal bias compared to isotope-dilution mass spectrometry (IDMS) reference methodology. * Undergoing workup for liver failure or listed for liver transplant. Patients with Gilbert's syndrome will be excluded if impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin * Unable or unwilling to use adequate birth control/contraceptive measures or abstain from sexual activity for 30 days following the study intervention * Anticipated need to donate ova or sperm within 30 days following study intervention
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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